Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00004494
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
1999-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014660', 'term': 'Vasoactive Intestinal Peptide'}], 'ancestors': [{'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '1999-10-18', 'studyFirstSubmitQcDate': '1999-10-18', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '1999-10-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['cardiovascular and respiratory diseases', 'immunologic disorders and infectious disorders', 'neonatal disorders', 'rare disease', 'respiratory distress syndrome', 'sepsis'], 'conditions': ['Sepsis', 'Respiratory Distress Syndrome', 'Respiratory Distress Syndrome, Adult']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Determine the maximum tolerated dose of vasoactive intestinal peptide in patients with acute respiratory distress syndrome.\n\nII. Evaluate the safety and pharmacodynamic activity of this peptide in these patients.', 'detailedDescription': 'PROTOCOL OUTLINE:\n\nThis is a dose escalation study.\n\nPatients receive vasoactive intestinal peptide (VIP) IV over either 6 or 12 hours.\n\nCohorts of 3 patients each receive escalating doses of VIP over either 6 or 12 hours until the maximum tolerated dose is determined.\n\nPatients are followed for 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nDiagnosis of adult respiratory distress syndrome (ARDS) with sepsis\n\nARDS characterized by: hypoxemia refractory to supplemental oxygen therapy, diffuse pulmonary infiltrates, no cardiogenic cause of pulmonary edema, and reduced pulmonary compliance\n\nSepsis characterized by: Two or more of the following: Fever or hypothermia; Tachycardia; Tachypnea; WBC greater than 12,000/mm3 or less than 4,000/mm3 or immature neutrophils; Hypotension; Clinical suspicion of infection; Inadequate organ perfusion or organ dysfunction as demonstrated by: Acute deterioration in mental acuity (excluding sedatives or other nonsepsis causes) OR Unexplained metabolic acidosis OR Oliguria for greater than 2 hours OR Unexplained coagulopathy (elevated PT or PTT or platelet count decreased to less than 50% of baseline within 24 hours or less than 100,000/mm3) OR Acute elevation of bilirubin to greater than 2.0 mg/dL AND elevation of alkaline phosphatase, SGOT, or SGPT\n\nNo sepsis with unstable BP\n\n--Prior/Concurrent Therapy--\n\nAt least 30 days since prior enrollment in investigational trial; No other concurrent enrollment in investigational trial\n\n--Patient Characteristics--\n\nHematopoietic: See Disease Characteristics; No uncontrolled hemorrhage (transfusion of 4 or more units required within past 24 hours); No chemotherapy induced neutropenia (granulocyte count less than 1000/mm3)\n\nHepatic: No severe liver disease with portal hypertension\n\nRenal: No anuria (urine output less than 50 mL/day)\n\nCardiovascular: No cardiogenic shock\n\nNeurologic: No recent stroke, head trauma, or increased intracranial pressure; No other serious neurologic disorder\n\nOther: Not pregnant; No acquired immune deficiency syndrome; No immunosuppressed transplant patients; No severe burns; No irreversible underlying condition with rapidly fatal course; No marked obesity; No recent history of diarrhea'}, 'identificationModule': {'nctId': 'NCT00004494', 'briefTitle': 'Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'orgStudyIdInfo': {'id': '199/14275'}, 'secondaryIdInfos': [{'id': 'SUNY-SB-FDR001488'}, {'id': 'SUNY-SB-96-077'}, {'id': 'SUNY-SB-98-2606'}, {'id': 'FD-R-0001488', 'type': 'OTHER_GRANT', 'domain': 'FDA Orphan Drug Products'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'vasoactive intestinal peptide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11768', 'city': 'Northport', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Northport', 'geoPoint': {'lat': 40.90093, 'lon': -73.34317}}, {'zip': '11790-7775', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Health Sciences Center - Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Sami I. Said', 'role': 'STUDY_CHAIR', 'affiliation': 'State University of New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'collaborators': [{'name': 'State University of New York', 'class': 'OTHER'}, {'name': 'FDA Office of Orphan Products Development', 'class': 'FED'}]}}}